Kamal-Bahl Sachin, Watson Douglas J, Ambegaonkar Baishali M
Merck & Co., Inc., West Point, Pennsylvania, USA.
Clin Ther. 2009 Jan;31(1):130-40. doi: 10.1016/j.clinthera.2009.01.011.
Niacin is highly effective at raising high-density lipoprotein cholesterol but remains underused because of the adverse event of flushing.
The objective of this study was to determine the incidence and severity of niacin-induced flushing and their relationship to niacin discontinuation and skipping or delaying niacin doses in clinical practice. The use of aspirin to avoid niacin-induced flushing was also assessed.
Structured telephone interviews were performed with patients identified from administrative claims data as having newly initiated niacin. The main outcome measures were rate and severity of flushing, association between flushing and niacin discontinuation, and rate of prophylactic aspirin use to avoid flushing. Flushing was evaluated on a scale of none, mild, moderate, severe, and extreme.
Telephone interviews were conducted with 500 patients who had newly initiated niacin. The patients interviewed were predominantly white men with at least some college education and a mean (SD) age of 55.0 (10.9) years. The mean (SD) time between therapy initiation and interview was 9.3 (3.3) months. At the time of the interview, 27.2% of respondents reported having discontinued niacin ("discontinuers"; n = 136), with a mean duration of niacin use of 4.3 months, and 72.8% continued taking niacin ("continuers"; n = 364). Approximately 91.2% (124/136) of niacin discontinuers and 82.1% (299/364) of continues reported experiencing flushing symptoms (P = 0.013), and 54.4% of discontinuers versus 20.9% of continuers experienced severe or extreme flushing (P < 0.001). Significantly more discontinuers (79.4%) than continuers (58.0%) reported that the greatest degree of flushing they could tolerate was "mild" or "moderate" (P < 0.001). Multivariate logistic regression indicated that flushing symptom severity was a strong predictor of discontinuation as compared with no flushing symptoms (severe: odds ratio [OR], 3.19; 95% CI, 1.43-7.15; extreme: OR, 11.29; 95% CI, 4.20-30.39). Similar percentages of discontinuers and continuers reported both receiving a physician's advice to take prophylactic aspirin (42.0% vs 49.5%, respectively; P = NS) and actually taking aspirin regardless of what their physicians advised (36.0% vs 43.7%; P = NS).
Severe or extreme symptoms of flushing, which occurred in about one third of patients newly treated with niacin, were associated with discontinuation of this otherwise highly effective therapy. Less than half of patients reported being advised by their physician to take prophylactic aspirin or took aspirin regardless of their physician's recommendation to avoid niacin-induced flushing symptoms.
烟酸在升高高密度脂蛋白胆固醇方面非常有效，但由于潮红这一不良事件，其使用仍不充分。
本研究的目的是确定烟酸引起的潮红的发生率和严重程度，以及它们与临床实践中停用烟酸和漏服或延迟服用烟酸剂量的关系。还评估了使用阿司匹林来避免烟酸引起的潮红的情况。
对从行政索赔数据中识别出的新开始使用烟酸的患者进行结构化电话访谈。主要结局指标为潮红的发生率和严重程度、潮红与停用烟酸之间的关联，以及使用预防性阿司匹林来避免潮红的比例。潮红程度按无、轻度、中度、重度和极重度进行评估。
对500名新开始使用烟酸的患者进行了电话访谈。接受访谈的患者主要是白人男性，至少接受过一些大学教育，平均（标准差）年龄为55.0（10.9）岁。从开始治疗到访谈的平均（标准差）时间为9.3（3.3）个月。在访谈时，27.2%的受访者报告已停用烟酸（“停用者”；n = 136），烟酸使用的平均持续时间为4.3个月，72.8%的患者继续服用烟酸（“继续使用者”；n = 364）。约91.2%（124/136）的烟酸停用者和82.1%（299/364）的继续使用者报告有潮红症状（P = 0.013），54.4%的停用者与20.9%的继续使用者经历了重度或极重度潮红（P < 0.001）。报告称自己能耐受的最大潮红程度为“轻度”或“中度”的停用者（79.4%）明显多于继续使用者（58.0%）（P < 0.001）。多因素逻辑回归表明，与无潮红症状相比，潮红症状严重程度是停用烟酸的有力预测因素（重度：比值比[OR]，3.19；95%置信区间，1.43 - 7.15；极重度：OR，11.29；95%置信区间，4.20 - 30.39）。停用者和继续使用者中报告既接受医生建议服用预防性阿司匹林（分别为42.0%对49.5%；P = 无显著差异）又实际服用了阿司匹林而不管医生建议如何的比例相似（36.0%对43.7%；P = 无显著差异）。
约三分之一新接受烟酸治疗的患者出现的重度或极重度潮红症状与停用这种原本非常有效的治疗方法有关。不到一半的患者报告医生建议他们服用预防性阿司匹林或不管医生建议而自行服用阿司匹林以避免烟酸引起的潮红症状。
